Conservative Endometrioma Surgery

NCT ID: NCT04151433

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-24

Study Completion Date

2026-12-31

Brief Summary

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To study which surgical technique offers better results in treating endometriomas in terms of ovarian reserve preservation.

The 2 conservatives techniques used are:

1. The combined technique
2. CO2 laser vaporization only

Ovarian reserve will be assessed by consecutive measurements of AMH serum levels before and after surgery.

Detailed Description

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Conditions

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Endometriosis Ovary Endometrioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The combined technique

First step consisting of stripping the cyst wall for 80% of the surface, followed by a second step consisting of ablation of the remaining 20% cyst surface.

Group Type ACTIVE_COMPARATOR

Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).

Intervention Type PROCEDURE

cf. different arms

CO2 laser vaporization only

CO2 laser vaporization only of the complete inner cystic wall after drainage of the cyst content, irrigation and inspection of its inner wall. Ablation of the inner cyst wall using the CO2 laser (Lumenis). Power settings of 30-55W for CO2 laser beam and 6-10W for CO2 fibre are used. The laser should be on the ablate function to widen the beam (e.g. Surgitouch modus). The laser should be applied in Surgitouch modus so that it can ablate the cyst surface while preserving the underlying healthy tissue.

Group Type ACTIVE_COMPARATOR

Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).

Intervention Type PROCEDURE

cf. different arms

Interventions

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Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).

cf. different arms

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age: 18 - 40 years (both inclusive)
* Unilateral endometriotic cysts with a mean diameter of \>=2.5cm and ≤8 cm, measured in 3 dimensions.
* Presence of a contralateral endometrioma of ≤ 2cm is allowed
* Complaining of infertility and/or pain
* BMI ≤35
* Use of contraception (combined or Progesteron only) for at least 4 weeks before surgery

Exclusion Criteria

* Incomplete surgery for the pelvis
* Contra-indication for the use of contraception (combined or Progesteron only)
* Use of GnRH analogues preoperatively and in the first 3 months postoperatively
* (History of) hysterectomy
* Prior unilateral oophorectomy
* Pituitary/hypothalamic disorders
* Suspected malignancy
* Contralateral endometrioma of \>2 cm
* AMH \<0.7 preoperatively
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GZA Ziekenhuizen Campus Sint-Augustinus

OTHER

Sponsor Role collaborator

Centre Hospitalier Régional de la Citadelle

OTHER

Sponsor Role collaborator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carla Tomassetti, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Leuven University Fertility Center

Locations

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GZA Sint-Augustinus

Antwerp, , Belgium

Site Status RECRUITING

Cliniques universitaires Saint-LUC (UCL)

Brussels, , Belgium

Site Status RECRUITING

UZLeuven

Leuven, , Belgium

Site Status RECRUITING

CHR La Citadelle

Liège, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Carla Tomassetti, MD, PhD

Role: CONTACT

Phone: +3216340825

Email: [email protected]

Celine Bafort, MD

Role: CONTACT

Phone: +3216340088

Email: [email protected]

Facility Contacts

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Brecht Geysenbergh, MD

Role: primary

Laurence Beausaert

Role: primary

Celine Bafort, MD

Role: primary

Marie Timmermans, Msc

Role: primary

References

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Bafort C, Lie Fong S, Fieuws S, Geysenbergh B, Nisolle M, Squifflet JL, Tebache L, Wyns C, Meuleman C, Tomassetti C. Conservative endometrioma surgery: The combined technique versus CO2-laser vaporization only (BLAST: Belgium LAser STudy): Clinical protocol for a multicenter randomized controlled trial. PLoS One. 2025 Mar 6;20(3):e0315709. doi: 10.1371/journal.pone.0315709. eCollection 2025.

Reference Type DERIVED
PMID: 40048474 (View on PubMed)

Other Identifiers

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S62899

Identifier Type: -

Identifier Source: org_study_id